Clinical Research Directory

Inclusion Criteria： 1. Inclusion Criteria （Subjects with Hepatic Impairment）: * Male and female subjects aged 18 to 75 years (inclusive); * Male subjects with body weight ≥ 50.0 kg and female subjects with body weight ≥ 45.0 kg, with body mass index (BMI) \[BMI = weight (kg) / height² (m²)\] between 18.0 and 30.0 kg/m² (inclusive); * Subjects with hepatic impairment caused by pre-existing primary liver disease (excluding drug-induced liver injury), with Child-Pugh classification of mild (Grade A) or moderate (Grade B); * Subjects who have had a stable medication regimen (including drug type, dosage, and frequency) for the treatment of hepatic impairment, complications of liver disease, and other concomitant diseases within 2 weeks prior to check-in or within 5 half-lives of concomitant medications (whichever is longer) through the end of the study period, without requiring adjustment, or subjects who were not on any medication prior to enrollment; * Subjects whose hepatic function status is assessed by the investigator as stable from 2 weeks prior to administration of the investigational drug through the end of the study period, without significant deterioration (e.g., abdominal pain, ascites, nausea, vomiting, anorexia, fever, or worsening of liver function-related laboratory results); * Subjects of childbearing potential (including their partners) who voluntarily agree to use appropriate contraceptive measures from 2 weeks prior to screening through 3 months after dosing, and who have no plans for sperm or egg donation; * Subjects who are able to understand and are willing to strictly comply with the clinical trial protocol to complete the study, and who have signed the informed consent form. 2. Inclusion Criteria Healthy Subjects: * Male and female subjects aged 18 to 75 years (inclusive), matched with subjects in Groups A and B by age and gender; * Male subjects with body weight ≥ 50.0 kg and female subjects with body weight ≥ 45.0 kg, with body mass index (BMI) between 18.0 and 30.0 kg/m² (inclusive), matched with subjects in Groups A and B by BMI; * Normal hepatic function; * Subjects with normal results from medical history inquiry, physical examination, vital sign monitoring, 12-lead electrocardiogram (ECG), laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function), alpha-fetoprotein (AFP), abdominal ultrasound (liver, spleen, gallbladder, pancreas, bilateral kidneys, ascites), and other imaging examinations, or with abnormalities deemed clinically insignificant by the investigator; * Subjects of childbearing potential (including their partners) who voluntarily agree to use appropriate contraceptive measures from 2 weeks prior to screening through 3 months after dosing, and who have no plans for sperm or egg donation; * Subjects who are able to understand and are willing to strictly comply with the clinical trial protocol to complete the study, and who have signed the informed consent form. Exclusion Criteria： 1. Exclusion Criteria （Subjects with Hepatic Impairment）: * Subjects with a confirmed allergy to Levornidazole Disodium Phosphate for Injection or any of its formulation components, or to other nitroimidazole drugs; or those with a history of drug or food allergies, or a history of specific atopic diseases (such as asthma, urticaria, eczema, etc.); * Subjects with special dietary requirements who cannot accept a unified diet; * Subjects with difficult venous blood sampling, inability to tolerate venipuncture, or a history of needle phobia or blood phobia; * Subjects who have undergone surgical procedures within 4 weeks prior to screening, or who plan to undergo surgery during the study period; * Subjects with a history of liver transplantation surgery; * Subjects with acute hepatic impairment or liver failure, or those with complications such as hepatic encephalopathy, hepatocellular carcinoma, esophageal and gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, etc.; or subjects with active hepatitis C (those who are HCV-Ab positive but have two HCV-RNA results below the lower limit of detection at an interval of 12 weeks or more may be enrolled); or subjects with active chronic hepatitis B (those who are HBsAg positive, HBeAg negative, and HBV-DNA \< 2×10³ IU/mL may be enrolled); * Subjects with diseases affecting bile excretion, such as biliary cirrhosis, biliary obstruction, or cholestatic liver disease; * Subjects with clinically significant abnormal HIV or syphilis screening results (those with syphilis antibody levels above the normal range but TRUST negative may be enrolled in this study); * Subjects with uncontrolled cardiac, respiratory, gastrointestinal, hematological, or neurological diseases, or other medical history that may affect the study results, as judged by the investigator; * Subjects whose laboratory test results at screening meet any of the following criteria: (a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10 × ULN; (b) Hemoglobin (HGB) \< 60 g/L; (c) Abnormal alpha-fetoprotein (AFP) levels suggestive of hepatocellular carcinoma (in combination with other imaging examinations such as liver ultrasound, CT, or MRI); * Subjects with uncontrolled or poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg); * Subjects with estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m²; * Subjects with a history of drug abuse or substance use, or a positive urine drug screening result; * Subjects who are regular drinkers within 3 months prior to check-in, i.e., consuming more than 14 units of alcohol per week (1 unit ≈ 360 mL beer, or 45 mL of 40% spirit, or 150 mL wine), or those who cannot abstain from any alcoholic products during the study period, or those with an alcohol breath test result \> 0 mg/100 mL; * Subjects who have donated blood or experienced significant blood loss (\> 400 mL), or received blood transfusions or blood products within 3 months prior to check-in, or those who plan to donate blood during the study period or within 1 month after the end of the study; * Subjects who smoke ≥ 5 cigarettes per day within 3 months prior to check-in, or those who do not agree to abstain from any tobacco products during the study period; * Subjects who consume excessive tea, coffee, and/or caffeinated beverages (more than 8 cups per day, 1 cup ≈ 250 mL) within 3 months prior to check-in, or those who do not agree to abstain from such beverages during the study period; * Subjects who have participated in a clinical trial and received an investigational drug within 90 days prior to screening, or those who plan to participate in another clinical trial during the study period; * Subjects who have received vaccination within 30 days prior to screening, or those who plan to receive vaccination during the study period; * Subjects who have used any drugs that inhibit or induce CYP or UGT enzymes within 30 days prior to check-in; * Subjects who have used any prescription drugs, over-the-counter drugs, vitamins, or herbal medicines within 14 days prior to check-in, except for those used to treat hepatic impairment or their concomitant chronic diseases; * Subjects who have consumed a special diet (including grapefruit, chocolate, or foods/beverages rich in xanthine) within 48 hours prior to check-in; * Female subjects who are lactating or pregnant; * Subjects who have developed acute diseases from the screening period to before dosing; * Subjects who are deemed unsuitable for inclusion by the investigator. 2. Exclusion Criteria （Healthy Subjects）: * Subjects with a confirmed allergy to Levornidazole Disodium Phosphate for Injection or any of its formulation components, or to other nitroimidazole drugs; or those with a history of drug or food allergies, or a history of specific atopic diseases (such as asthma, urticaria, eczema, etc.); * Subjects with special dietary requirements who cannot accept a unified diet; * Subjects with difficult venous blood sampling, inability to tolerate venipuncture, or a history of needle phobia or blood phobia; * Subjects with any clinically significant abnormality in hepatitis B surface antigen (HBsAg), syphilis-specific antibody, human immunodeficiency virus antigen/antibody (HIV Ag/Ab), or hepatitis C virus antibody (HCV-Ab); * Subjects with a history of severe diseases of the respiratory, circulatory, digestive, urinary, hematological, endocrine, immune, neurological, or psychiatric systems; * Subjects who have undergone surgical procedures within 4 weeks prior to screening, or who plan to undergo surgery during the study period; * Subjects with a history of drug abuse or substance use, or a positive urine drug screening result; * Subjects who are regular drinkers within 3 months prior to check-in, i.e., consuming more than 14 units of alcohol per week (1 unit ≈ 360 mL beer, or 45 mL of 40% spirit, or 150 mL wine), or those who cannot abstain from any alcoholic products during the study period, or those with an alcohol breath test result \> 0 mg/100 mL; * Subjects who have donated blood or experienced significant blood loss (\> 400 mL), or received blood transfusions or blood products within 3 months prior to check-in, or those who plan to donate blood during the study period or within 1 month after the end of the study; * Subjects who smoke ≥ 5 cigarettes per day within 3 months prior to check-in, or those who do not agree to abstain from any tobacco products during the study period; * Subjects who consume excessive tea, coffee, and/or caffeinated beverages (more than 8 cups per day, 1 cup ≈ 250 mL) within 3 months prior to check-in, or those who do not agree to abstain from such beverages during the study period; * Subjects who have participated in a clinical trial and received an investigational drug within 90 days prior to screening, or those who plan to participate in another clinical trial during the study period; * Subjects who have received vaccination within 30 days prior to screening, or those who plan to receive vaccination during the study period; * Subjects who have used any drugs that inhibit or induce CYP or UGT enzymes within 30 days prior to check-in; * Subjects who have used any prescription drugs, over-the-counter drugs, health supplements, vitamins, or herbal medicines within 14 days prior to check-in; * Subjects who have consumed a special diet (including grapefruit, chocolate, or foods/beverages rich in xanthine) within 48 hours prior to check-in; * Female subjects who are lactating or pregnant; * Subjects who have developed acute diseases from the screening period to before dosing; * Subjects who are deemed unsuitable for inclusion by the investigator.